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For medical device registration in the United States, the requirement for a clinical evaluation report (CER) depends on the device's classification and intended use. Here’s a breakdown based on device classes:

1. Class I Devices: Typically low-risk devices such as tongue depressors or elastic bandages do not usually require clinical data or a CER for FDA registration. Manufacturers can demonstrate safety and effectiveness through existing literature or by showing substantial equivalence to predicate devices.

2. Class II Devices: Moderate-risk devices, such as powered wheelchairs or some pregnancy test kits, may require clinical data to support safety and performance claims. This could include clinical studies, literature reviews, or other forms of clinical evidence. A CER may be necessary to summarize and evaluate this clinical data.

3. Class III Devices: High-risk devices, such as implantable pacemakers or new types of diagnostic tests, typically require extensive clinical data, including controlled clinical trials. A comprehensive CER is often mandatory to assess the clinical evidence supporting the device's safety and effectiveness.

The FDA's regulatory requirements emphasize the importance of demonstrating that medical devices are safe and effective for their intended use. For devices that necessitate clinical data, the FDA expects thorough documentation and analysis in the CER to support regulatory submissions such as premarket notifications (510(k)), premarket approval applications (PMA), or De Novo classification requests.

Manufacturers must ensure that clinical studies comply with FDA's Good Clinical Practice (GCP) guidelines, which govern the design, conduct, and reporting of clinical trials. The CER should provide a detailed summary and evaluation of the clinical evidence, including the device's benefits, risks, and overall performance compared to alternative treatments or devices.

In summary, while not all medical devices require clinical evaluation reports for FDA registration, devices classified as Class II and Class III often do. Manufacturers should carefully assess FDA regulations and guidance applicable to their device classification to determine the specific requirements for clinical data and the necessity of a comprehensive CER to support their regulatory submissions.

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